FUJIFILM Holdings America Corporation · 10 hours ago
Analyst, Quality Control Bioassay
US-NC-Holly Springs
Full-time
Onsite
New Grad, Entry Level
0+ years expFUJIFILM Holdings America Corporation is building the future of bioproduction in Holly Springs, North Carolina. The Quality Control Bioassay Analyst will execute QC cell- and plate-based analytical methods, adhere to GMP compliant laboratory operations, and generate analytical results while identifying exceptions and implementing corrective actions.
Artificial Intelligence (AI)Machine LearningMotion CapturePhotographyPrinting
Responsibilities
Executes cell- and plate-based analytical methods including protein binding assays (e.g. ELISA, Dot Blot, etc.), cell-based potency assays, cell culture maintenance, and residual testing for DNA, Host Cell Protein (HCP), Protein A/G
Ensures analytical testing of in process, drug substance (DS), drug product (DP) and stability samples are performed according to appropriate GMP regulations
Ensures analytical testing data is captured in LIMS software and data integrity is maintained
Reports assay performance and assists with implementing improvements that ensure quality and efficiency within QC Bioassay
Identifies and follows-up on excursions and deviations and initiate corrective and preventative actions (CAPAs)
Coordinates and supports QC Bioassay lab activities, as needed
Supports laboratory execution of analytical method transfers and validations
Assists with authoring and reviewing QC SOPs
Works cross functionally with other QC departments, Manufacturing, Process Science, and Quality Assurance stakeholders to achieve customer and FUJIFILM Biotechnologies objectives
Performs other duties, as assigned
Qualification
Required
Bachelor's degree in life sciences, Virology, Biology, Chemistry, Biochemistry or related science field with 0 - 2 years of experience
0-2 years GMP laboratory experience
Preferred
Experience with LIMS software
Company
FUJIFILM Holdings America Corporation
For over 90 years, Fujifilm has found #ValueFromInnovation through expanding its portfolio to represent a broad spectrum of industries including medical and life sciences, electronic, chemical, graphic arts, information systems, industrial products, broadcast, data storage, and photography.
10001+ employees
H1B Sponsorship
FUJIFILM Holdings America Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2022 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2006-06-13Acquired
Leadership Team
Deepak Mahulikar
Chief Technology Officer
Patrícia Colombo
Chief Compliance Officer
Company data provided by crunchbase